OGD Perspectives

1. GPhA Fall Technical Conference OGD Perspectives Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005

2. Topics • Productivity • Operations Issues • New Endeavors • Positive Progress • Industry Contribution FDA/GPhA Fall Technical Conference

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6. Office of Generic Drugs FDA/GPhA Fall Technical Conference

7. Operations Issues FDA/GPhA Fall Technical Conference

8. Hiring On Board Change (over FY) • IO 37 - • Chem I 26 +1 • Chem II 26 +1 • Chem III 19 - 3 • BioEquiv 43 +8 • LPS 50 +2 • TOTAL 201 9 Oct 2005 FDA/GPhA Fall Technical Conference

9. Hiring Process Delays • Often takes 6 months or more, from initial contact, to complete the hiring process • Has been difficult to hire enough additional reviewers to address the increase in submissions • We continue to fall behind – especially in Division of Bioequivalence and Microbiology staffs FDA/GPhA Fall Technical Conference

10. 7519 Standish 7500 Standish Immediate Office Move FDA/GPhA Fall Technical Conference

11. Staff Affected by Move to 7519 Standish Place Robert Lionberger Patti Littleton Cecelia Parise Genie Patrick Andre Raw Dave Read Ruth Warzala Kristin West Lawrence Yu Gary Buehler Pat Downs Sam Haidar Don Hare Rita Hassall Hyojong Kwon Melissa Lamb LaiMing Lee Sau Lee FDA/GPhA Fall Technical Conference

12. CDER Offices at White Oak • Office of Pharmaceutical Science (except OGD) • Office of Counter Terrorism and Pediatric Drug Development • Office of Clinical Pharmacology and Biopharmaceutics • Office of New Drugs • Office of Medical Policy (including DDMAC) • Office Pharmacoepidemiology and Statistical Science FDA/GPhA Fall Technical Conference

13. CDER Offices at White Oak • Effect on OGD • More difficult to communicate with OND and OPS directly • More time devoted to travel between FDA buildings • We believe it is critical to maintain face-to-face contact with these and other offices in CDER FDA/GPhA Fall Technical Conference

14. Review Issues • Overall review workload as noted • PEPFAR • Petitions – actively working on 14 • Emphasis on safety concerns, e.g., isotretinoin; transdermals FDA/GPhA Fall Technical Conference

15. New Endeavors – IO Perspective • Structured Product Labeling (SPL) • Makes labeling available on Internet via National Library of Medicine (NLM) • Review Efficiencies • Early DMF review • Cluster reviews – product specialists • Supplement triaging at team leader level • DBE Truncated Review • Question based Review (QbR) • Will have a very positive impact FDA/GPhA Fall Technical Conference

16. On a Positive Note... • New resources developed • Dissolution Database • Individual Product Bioequivalence Information • Encouraged the use of telephone in review process • Increased the number of 1st cycle approvals • Decreased the total number of review cycles • Total time to approval did not increase in spite of increased workload FDA/GPhA Fall Technical Conference

17. New!! Dissolution Methods for Drug Products FDA/GPhA Fall Technical Conference

18. ben FDA/GPhA Fall Technical Conference

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20. This guidance contains an Internet linkto a listing of drug products, each linked in turn to a corresponding bioequivalence recommendation. Clicking on a product name in that list will bring up the bioequivalence recommendations for that specific product. Recommendations have been developed for several drugs that are not yet eligible for generic competition (i.e., newly approved products) and some older products for which information has previously been provided. As additional recommendations are developed, those will be posted on the Web site. When this guidance is finalized, the listing will be available through the Agency’s Web page. FDA/GPhA Fall Technical Conference

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22. Industry Contribution FDA/GPhA Fall Technical Conference

23. You Can Help • Participate in the new initiatives • Respond quickly • Utilize available online resources • Submit applications electronically • Provide feedback on OGD processes FDA/GPhA Fall Technical Conference

24. You Can Help - Microbiology • Changes to Container/Closure System • Glass Vials (e.g., change from Type II to Type I, or vial vendor change) a) Identical vial opening dimensions: no C/C integrity validation needed, b) Non-identical opening dimensions: perform C/C integrity validation • Stoppers (change in rubber formulation): • Perform C/C integrity validation FDA/GPhA Fall Technical Conference

25. You Can Help - Microbiology • General Supplement Info: • Note (in cover letter) ANDA/NDA/Supplement numbers in which the change was previously submitted/approved • Note (in cover letter) whether the newly submitted information is identical to or represents updated information contained in the initial supplement FDA/GPhA Fall Technical Conference

26. You Can Help - Microbiology • General Supplement Info – continued: • For minor (“Micro Only”) changes affecting multiple applications, OGD Micro is amenable to a single initial supplement filing followed by AR filing for subsequent reporting of the same change, provided all affected applications or products are delineated in the initial supplement. • Otherwise, products not listed in the initial supplement would require CBE-30/0 supplement FDA/GPhA Fall Technical Conference

27. A Final Word Emphasis on safetyMaintaining integrity of generic drug review FDA/GPhA Fall Technical Conference

28. Center for Drug Evaluation and ResearchOffice of Generic Drugs HFD-600 7500 Standish Place Rockville, MD 20855 301-827-5845 FDA/GPhA Fall Technical Conference